The Regulatory Affairs Specialist is responsible for executing the regulatory strategy and deliverables for the Beckman Coulter Molecular products and processes. This includes
FDA Pre-IDE, 510(k), PMA
EU technical files and dossiers
Health Canada license applications
Other international submissions, as needed
Monitor and contribute to the process of corrective and preventive action to assure timeliness and effectiveness of the system.
MDRs and Vigilance Reports
Review and approval of labels and literature to support commercialized products.
Participates on cross segment and Corporate Teams.
Keeps abreast of US and non-US regulations affecting own area of specialization and complies with those regulations.
Initiates, collaborates and supports compliance and continuous improvement projects that effect customer satisfaction and revenue.
Initiates changes to Quality System procedures and processes to support compliance and improvement activities.
Participates in the training of other employees
Performs other related duties and assignments as required.

Qualifications

Demonstrated ability to perform detail-oriented work with a high degree of accuracy.

Working knowledge of US and international regulations (QSR, ISO, IVDD, MDD, GLP, cGMP, CLIA).

Excellent organization, planning and execution skills.

Excellent oral and written communication skills.

RAC certification preferred.

Effective analytical, quantitative, and problem solving skills with the ability to communicate and teach others.

Experience with design controls

Three years of direct regulatory experience

Danaher Overview
Danaher is a diversified technology leader that designs, manufactures, and markets innovative products and services to professional, medical, industrial, and commercial customers. Our portfolio of premier brands is among the most highly recognized in each of the markets we serve. Danaher's portfolio is comprised of five reporting segments: Test & Measurement; Environmental; Life Sciences & Diagnostics; Dental; and Industrial Technologies. Driven by a foundation provided by the Danaher Business System, Danaher's 48,000 associates serve customers in more than 125 countries and generated $13.2 billion of revenue in 2010.
Organization
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Beckman Coulter